Recently, a bipartisan set of Senators – Senator Dick Durbin and Senator Mike Braun – sent a letter to United States Food and Drug Administration Commissioner Robert M. Califf, MD, urging him to update the agency’s enforcement tools to better reflect the current social media platforms that are being used to promote prescription drugs. The Senators note that changes are needed, at least in part to protect children from harmful and inaccurate medical advice.
The Senators refer to studies that “show that patients are more likely to ask their provider for a particular medication and to receive a prescription if the patient has seen a direct-to-consumer (DTC) advertisement for the drug,” which can “inflate demand for medications that may not be clinically appropriate, or for which alternative interventions may be available.” They go on to note that “there are gaping holes in FDA’s oversight of [direct-to-consumer] DTC promotions that are being exploited on social media at the expense of children and patients.”
The last time the FDA updated its draft guidance on prescription drug promotion for social media was in 2014. Since that time, the social media landscape has shifted dramatically, including the increase in time that users (especially minors) spend on social media platforms. Additionally, since that time we have seen a rise in social media influencers, who may fail to disclose a financial relationship with a pharmaceutical manufacturer. Influencers tend to be trusted by their followers and some may even be considered experts by their following. These types of promotions can lead to overstating of benefits of a particular drug and/or minimizing the potential harm.
Therefore, the Senators believe, “the agency’s decade-old guidance must be modernized,” including “clarify[ing] that these platforms are subject to its jurisdiction and should reflect the way that advertisements on these platforms must comply with federal requirements – such as conspicuousness and duration of statements, and size/contrast of imagery, including accounting for character counts and other limitations.” The Senators also point to public comment sections as an area that the FDA should pay particular attention to in updating its guidance.
The Senators note that, “the power of social media and the deluge of misleading promotions has meant too many young people are receiving medical advice from influencers instead of their health care professional. Only seven of FDA’s publicly available warning and untitled letters issued since 2017 relate to social media content.” They ask the FDA why it has only taken public enforcement action in social media matters in seven instances since 2017 and how each of those cases were identified by the FDA.
One of the asks that the Senators make in their letter is for the FDA to commit to updating the 2014 guidance document to “reflect the current public health threats and regulatory gaps that exist from the current nature of social media use” by the end of this year.
The Senators conclude the letter by saying, “the threats to children from misleading and unsubstantiated advertisements necessitate action. You have called health misinformation and disinformation a leading cause of death in the United States—and it is time the FDA addresses this challenge.”